Kornimate/medical-research-clean huggingface dataset:
norepinephrine prophylaxis for postspinal anesthesia hypotension in parturients with preeclampsia.

Conditions: Adverse Effect

Summary: the purpose of this study is to investigate the suitable infusion dose of norepinephrine for prophylaxis against postspinal anesthesia hypotension in parturients with preeclampsia undergoing cesarean section.

preeclampsia, which affects 5% to 7% of parturients, is a significant cause of maternal and neonatal morbidity and mortality. because of constricted myometrial spiral arteries with exaggerated vasomotor responsiveness, though blood pressure in parturients with preeclampsia are apparently higher than healthy parturients, placental hypoperfusion is more common. spinal anesthesia is still the preferred mode of anesthesia in parturients with preeclampsia for cesarean section. in preeclampsia parturients, spinal anesthesia improve intervillous blood flow (provided that hypotension is avoided) which contribute to increase placental perfusion. even so, 17-26% parturients with preeclampsia experienced postspinal anesthesia hypotension due to the extensive sympathetic block that occurred with spinal anesthesia. as a potential substitute drug for phenylephrine and ephedrine, norepinephrine has gained traction for use in parturients undergoing cesarean section. but the suitable infusion dose of norepinephrine in parturients with preeclampsia is still unknown. the purpose of this study is to investigate the suitable infusion dose of norepinephrine for prophylaxis against post-spinal anesthesia hypotension in parturients with preeclampsia undergoing cesarean section.

Eligibility criteria:
inclusion criteria: * 18-45 years * primipara or multipara * singleton pregnancy ≥32 weeks * american society of anesthesiologists physical status classification ii to iii * scheduled for cesarean section under spinal anesthesia exclusion criteria: * baseline blood pressure ≥180 mmhg * body height \< 150 cm * body weight \> 100 kg or body mass index (bmi) ≥ 40 kg/m2 * eclampsia or chronic hypertension * hemoglobin \< 7g/dl * fetal distress, or known fetal developmental anomaly

Keywords: norepinephrine postspinal anesthesia hypotension preeclampsia cesarean section dose-finding
a proof-of-principle study of oral treatment of non-alcoholic steatohepatitis with a novel pde4 inhibitor asp9831

Conditions: Non-Alcoholic Steatohepatitis

Summary: the aim of this study is to explore the effect of a new drug (asp9831) in patients with non-alcoholic steatohepatitis (nash) by assessing clinical signs, laboratory data and biomarkers during a 12 week treatment period

the study includes an open-label sub-study prior to the main study

Eligibility criteria:
inclusion criteria: * nash, histologically confirmed by a liver biopsy performed within 1 year prior to first dose and randomization * elevated serum alt levels exclusion criteria: * hepatic cirrhosis * other known cause of liver disease * uncontrolled diabetes mellitis type 2, i.e. hba1c \> 8.5% * positive history of tuberculosis or a positive ppd skin test which is not explained by previous bcg vaccination * history of excessive alcohol abuse within 5 years prior to screening or a current average alcohol intake of more than 20 g/day (2 units) for females or more than 30 g/day (3 units) for males * subject has used drugs associated with steatohepatitis within 6 months prior to screening (corticosteroids, high dose estrogens, methotrexate, amiodarone, anti-hiv drugs, tamoxifen)

Keywords: nash chronic liver disease
nmf-csa-dupi trial

Conditions: Dermatitis, Atopic

Summary: the goal of this study is to investigate whether stratification of children with atopic dermatitis on the nmf biomarkers results in an improvement of effectiveness and efficiency in the use of systemic treatment (ciclosporin and dupilumab) in moderate-to-severe atopic dermatitis.


Eligibility criteria:
inclusion criteria: * children and adolescents, aged 2-18 years, with moderate-to-severe atopic dermatitis (diagnosed according to the uk working party criteria) * patient and parents/guardians able to participate in the study and willing to give written informed consent * easi (eczema area severity index) ≥ 6 at screening and baseline (corresponding with moderate-to-severe disease) * iga (investigator global assessment) ≥ 3 at screening and baseline (corresponding with moderate-to-severe disease) exclusion criteria: * children under the age of 2 years and patients older than 18 years * contraindication for ciclosporin * contraindication for dupilumab * patient (or one of the parents/guardians) not willing to be randomized * children with a history of any known primary immunodeficiency disorder * children with a history of cancer * easi \< 6 at screening or baseline * iga \< 3 at screening or baseline

Keywords: natural moisturizing factor systemic treatment
protocolized vs discretionary use of opioids in acute pain

Conditions: Pain

Summary: we are testing whether patients who received protocolized pain management (1 mg of iv hydromorphone followed by an additional 1 mg intravenous (iv) hydromorphone 15 minutes later if the patients wants more) will have better pain relief and no more adverse events than patients receiving discretionary care, in which the patients receives whatever iv opioid the treating physician wants to give, in whatever dose.


Eligibility criteria:
inclusion criteria: 1. age 21 to 64 years. 2. pain with onset within 7 days. 3. emergency department attending physician's judgment that patient's pain warrants use of intravenous opioids. 4. normal mental status. exclusion criteria: 1. prior use of methadone. 2. use of other opioids, tramadol, or heroin in the past seven days. 3. prior adverse reaction to morphine, hydromorphone, or other opioids. 4. chronic pain syndrome. 5. alcohol intoxication. 6. systolic blood pressure \< 90 mm hg. 7. use of monoamine oxidase (mao) inhibitors in past 30 days. 8. weight less than 100 pounds. 9. baseline room air oxygen saturation less than 95%. 10. c02 measurement greater than 46: in accordance with a number of similar studies that we have performed, four subsets of patients will have their co2 measured using a handheld capnometer prior to enrollment in the study. if the co2 measurement is greater than 46, then the patient will be excluded from the study. the 4 subsets are as follows: 1. all patients who have a history of chronic obstructive pulmonary disease (copd) 2. all patients who have a history of sleep apnea 3. all patients who report a history of asthma together with greater than a 20 pack-year smoking history 4. all patients reporting less than a 20 pack-year smoking history who are having an asthma exacerbation

Keywords: hydromorphone acute pain protocolized efficacy safety
the efficacy of radial extracorporeal shockwave therapy on knee osteoarthritis

Conditions: Osteoarthritis, Knee

Summary: this is a double-blind placebo controlled trial whose objective is to understand how much the radial extracorporeal shockwave therapy can improve function of patients with knee osteoarthritis. for this trial, patients with knee osteoarthritis, after signing the informed consent form and having their demographic and baseline information collected, will be randomly allocated into one of both treatment arms: radial extracorporeal shockwave therapy (reswt) or sham radial extracorporeal shockwave therapy. then, they will undertake three sessions of reswt, for three weeks, i.e. one session per week. patients will be assessed prior to the therapy, one week after the end of the therapy and three months after the end of the therapy, and the primary outcome of this study is the functional change measured by the knee injury and osteoarthritis outcome score (koos) validated in portuguese, three months after the end of the therapy. secondary outcomes, will be the change of pain, the change of pressure pain tolerance threshold, change in diffuse noxious inhibitory control (dnic), and thermographic changes.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of knee osteoarthritis; * onset knee pain with moderate or severe intensity: visual analogue scale (vas) \> 4; * onset knee pain over 3 months prior to the inclusion; exclusion criteria: * presence of psychiatric disease; * presence of fibromyalgia; * presence of systemic inflammatory rheumatic diseases; * history of neoplasia; * presence of clinical diseases in other joints; * ongoing use of anticoagulant drugs.
an observational drug utilization study of asenapine in the united kingdom (p08308)

Conditions: Bipolar Disorder

Summary: this study is designed to describe asenapine prescribing patterns in the united kingdom (uk) during the post-approval period under conditions of usual practice. the use of asenapine in bipolar disorder and other indications will be described. to provide epidemiological and clinical perspective, use of aripiprazole and other comparator drugs will be described.

the data source for this study will be the clinical practice research database (cprd) in the uk. new users of asenapine during the period following the uk marketing launch of asenapine will be identified in the cprd. use in bipolar disorder and other indications, as well as baseline demographic and physical characteristics, including prior health status, comorbidities, concomitant medications and healthcare resource utilization, will be described for the asenapine cohort, for participants aged 18 or greater. use of asenapine in the general practice setting among pediatric participants will be described. the primary comparison cohort will be aripiprazole. participants in the aripiprazole cohort will be matched to participants treated with asenapine based on respective time after market entry. in addition, non-matched cohorts will be used to describe utilization of aripiprazole and other comparators.

Eligibility criteria:
inclusion criteria for participants treated with asenapine: * at least 1 prescription for asenapine within the study period * date of prescription occurs after the cprd subject registration date or the database specific quality indicator date * a minimum of 365 or more days of evaluable baseline observation time, occurring prior to the date of prescription for asenapine inclusion criteria for participants treated with a comparator: * age 18 years or greater at the time participant receives a prescription for the comparator * at least 1 prescription for either aripiprazole, quetiapine, risperidone, olanzapine, ziprasidone, iloperidone, paliperidone, lurasidone, clozapine, amisulpride, sertindole or zotepine within the study period * date of prescription occurs after the cprd subject registration date or the database specific quality indicator date * a minimum of 365 or more days of evaluable baseline observation time, occurring prior to the date of prescription for either aripiprazole, quetiapine, risperidone, olanzapine, ziprasidone, iloperidone, paliperidone, lurasidone, clozapine, amisulpride, sertindole or zotepine exclusion criteria: * none
validity and reliability of the postural habits and awareness scale

Conditions: Fibromyalgia

Summary: the aim of this study was to examine the validity and reliability of the turkish version of the postural habits and awareness scale in fibromyalgia patients.

postural habit and awareness scale is a scale developed for healthy individuals. for this reason, when applying to any disease group, other parameters belonging to that disease group should also be evaluated. for this purpose, fibromyalgia impact questionnaire, body perception scale, body awareness questionnaire, visual analog scale and short form-12 questionnaires were also used in the study. fibromyalgia is a disease that affects the whole body and generally causes pain and stiffness complaints. for this reason, the whole body should be evaluated. fibromyalgia impact questionnaire was used to define and indicate the level of fibromyalgia effects of the patients. for validity and reliability analyses, body perception scale and body awareness questionnaire questionnaires were used to compare the postural habit and awareness scale. at the same time, short form-12 questionnaire was used to examine the patients' pain severity and the effects of the disease on daily life.

Eligibility criteria:
inclusion criteria: * those who have been diagnosed with fibromyalgia according to the american rheumatology association criteria and have been over for at least 6 months, * those who do not have a history of any psychiatric disease, * those who have the ability to lie down, sit and stand without any assistance. exclusion criteria: * pregnant individuals, * those who have pain complaints due to another disease (rheumatic, heart or infectious diseases), * those who make changes in physical activity and lifestyle during work, * those with any neurological disease

Keywords: reability validity postural habit and awareness scale
clinical investigation to assess the acid neutralisation activity of a calcite chewing gum

Conditions: Esophagitis; Gastro Oesophageal Reflux Disease

Summary: this investigation is designed to evaluate the acid neutralisation action of a new test product versus unmatched placebo.

the primary objective of this confirmatory clinical investigation is to evaluate the acid neutralisation action of a calcite chewing gum, by comparing the antacid action with an unmatched placebo chewing gum. the clinical investigation will also assess the efficacy and safety of the calcite chewing gum.

Eligibility criteria:
inclusion criteria: 1. patient with a primary diagnosis of symptomatic gord in accordance with the montreal definition. patients must have experienced frequent troublesome heartburn and / or regurgitation (with or without dyspepsia symptoms) of mild/moderate intensity. if the patient also has other symptoms, the heartburn, regurgitation or dyspepsia should be the predominant symptoms. 2. patient that are healthy (with the exception of a diagnosis of gord) as determined by past medical history and vital signs at screening. exclusion criteria: 1. patients with a history or active gastrointestinal disease (gastroduodenal ulcer, gastrointestinal haemorrhage, mechanical obstruction or perforation) or hiatus hernia which is greater than 3 cm or a history of conditions that can lead to abnormal oesophageal ph. 2. patients experiencing frequent troublesome heartburn and / or regurgitation (with or without dyspepsia symptoms) of severe intensity 3. patients who are unwilling to refrain from using antacids or alginates 24 hours prior to the start of the treatment visit. 4. patients who are unwilling to refrain from using proton pump inhibitors (ppis), h2 antagonists, motility stimulants or other medicines for relief of symptoms of acid reflux disease 2 weeks prior to the start of treatment period.

Keywords: gastro-oesophageal reflux disease
meta-analysis of stannous fluoride and the effects on enamel erosion

Conditions: Enamel Erosion

Summary: the aim of this 5 study analysis was to compare the effect of bioavailable stannous fluoride (snf2) dentifrices to assess enamel erosion protection in-situ using surface profilometry.


Eligibility criteria:
inclusion criteria: * healthy subjects
physician acceptance of the neutrace system for cardiac electroanatomic mapping

Conditions: Arrhythmias, Cardiac; Atrial Fibrillation; Atrial Flutter

Summary: the trial is a prospective, non-randomized, single-arm feasibility trial to evaluate physician acceptance of the neutrace system v1.0 for cardiac electroanatomic mapping.

arrhythmias, or abnormal heart rhythms, are a major cause of morbidity and mortality worldwide. in patients with arrhythmias, electrophysiology (ep) studies are often performed to assess the electrical system of the heart. since its introduction in the 1990s, electroanatomic mapping has become a cornerstone of ep studies. electroanatomic mapping systems allow for non-fluoroscopic navigation of the heart and the creation of three-dimensional (3d) anatomic and electroanatomic maps. these maps facilitate diagnosing and treating arrhythmias. the neutrace system is a cardiac ep mapping system that is intended to be used during catheter-based atrial and ventricular mapping procedures. the system is designed to acquire and analyze data points and use this information to display 3d anatomical and electroanatomic mapping of the human heart. the system is used with a compatible, marketed magnetic sensor-enabled catheter and compatible ep recording system to acquire the location information and local electrogram needed to create the cardiac maps. the purpose of the trial is to evaluate physician acceptance and feasibility of the neutrace system v1.0 for cardiac electroanatomic mapping.

Eligibility criteria:
inclusion criteria: * patient with standard indications for an electrophysiology study and/or catheter ablation per european heart rhythm association/heart rhythm society) guidelines and/or judgement of the investigator * age 18 to 80 * signed informed consent form exclusion criteria: * any cardiac surgery, myocardial infarction, percutaneous coronary intervention/percutaneous transluminal coronary angioplasty, or coronary artery stenting which occurred during the 90-day interval preceding the date that participant signed the informed consent form * unstable angina * nhya class iii or iv congestive heart failure and/or known left ventricular ejection fraction less than 45% * thrombocytosis, thrombocytopenia * contraindication to anticoagulation therapy * active systemic infection * cryoglobulinemia * known reversible causes of arrhythmia * any cerebral ischemic event (stroke or transient ischemic attacks) which occurred during the 180-day interval preceding the date the participant signed the informed consent form, or any known unresolved complications from the previous stroke/transient ischemic attack * pregnancy * unwilling or unable to comply fully with study procedures

Keywords: cardiac arrhythmias atrial fibrillation atrial flutter electroanatomic mapping
safety and efficacy study of besivance™ for treatment of congenital nasolacrimal duct obstruction in children

Conditions: Congenital Nasolacrimal Duct Obstruction

Summary: the goal of the study is to evaluate the application of besivance™ (besifloxacin ophthalmic suspension, 0.6%) to treat congenital nasolacrimal duct obstruction in children. the hypothesis of the study is that besivance™ is as safe and effective as the current standard of care for the treatment of nasolacrimal duct obstruction in children.

the primary objective of this study is to evaluate the safety and efficacy of besivance™ as an antibiotic treatment for congenital nasolacrimal duct obstruction with infection in children. the primary outcome measure is the change from baseline on the physician rated scale of nasolacrimal duct obstruction (nldo)with infection to follow-up visit #2 (week 8) or at the time of treatment failure, if earlier.

Eligibility criteria:
inclusion criteria: * persons who have been diagnosed with congenital nasolacrimal duct obstruction (nldo) with infection by the principal investigator * both males and females * persons who are age of 1 to 12 months at time of diagnosis (time of diagnosis is defined as when the principal investigator makes clinical diagnosis.) exclusion criteria: * persons who have received any antibiotic treatment for nldo with infection for more than 2 week in the past 4 weeks. * persons who are currently receiving systemic antibiotic treatment that cannot be discontinued. * persons with any other ocular anomalies that could potentially interfere with interpretation of study results. * persons who have had any prior nasolacrimal duct system procedures such as stenting or probing. * persons who have previously participated in any clinical trial(s) of besivance™ * persons who have participated in any other clinical trial(s) of any investigational agent(s) within 30 days prior to the baseline visit * persons who have any chronic diseases that might interfere with study participation
spanish-language version of the kihon checklist

Conditions: Frailty

Summary: the purpose of this cross-sectional study is to validate the spanish version of the kihon checklist for screening frailty in spanish community-dwelling older adults.

in order to identify individuals at risk for frailty, a wide variety of assessment tools have been developed in recent years. nevertheless, there is still a lack of a gold standard method to be used. therefore, simple, reliable, and valid instruments are still needed for both research and clinical purposes. the kihon checklist is a multidimensional tool widely used in japan and in other countries, but an exhaustive validity in spanish population has not been yet established. the main objective is to validate the spanish version of the kihon checklist for screening frailty in spanish community-dwelling older adults, and as a secondary objective, to study and to compare different scales of frailty in the spanish population, and to study their associations. to cope with the objectives of the present study, a cross-sectional study was conducted. to this purpose, data were collected through various tests and questionnaires about: frailty; clinical, demographic and anthropometric characteristics; physical assessment; functional status; cognitive function; health-related quality of life; depressive mood; and nutritional status.

Eligibility criteria:
inclusion criteria: * age ≥ 65 years * community-dwelling older adults exclusion criteria: * barthel index \< 85 points considering as disabled * mini-mental state examination \< 18 points * acute disease * unstable chronic disease

Keywords: frailty spanish older adults
a multicenter, real-world study of adebrelimab in the treatment of extensive stage small cell lung cancer

Conditions: SCLC,Extensive Stage

Summary: this study collected data on patients with extensive stage small cell lung cancer treated with adebrelimab to investigate its safety and efficacy


Eligibility criteria:
inclusion criteria: 1. sign informed consent and join the study voluntarily; 2. patients diagnosed with extensive small cell lung cancer; 3. age ≥18 years old; 4. have at least one measurable lesion (according to recist 1.1); 5. the investigators judged that adebrelimab treatment was acceptable; 6. contraception: patients should agree that it must be used during the study period and within 6 months after the study ends effective contraception; exclusion criteria: 1. allergic to adebrelimab and its excipients; 2. patients who have also received other immune drugs or therapies; 3. patients who are participating in other interventional studies; 4. patients with other malignant tumors; 5. pregnant or lactating women; 6. the investigator considers that the patient is not suitable to participate in any other conditions of the study.